A Study of GIC-1001 for the Management of Visceral Pain During Sedation-Free, Full Colonoscopy


About this study

The purpose of this study is to assess the effectiveness and safety of GIC-1001, a new, orally-administered, colon analgesic drug, developed to manage visceral pain, as an alternative to sedation during a full colonoscopy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study has been completed

Inclusion Criteria

  • Signed and dated written Informed Consent obtained
  • Males or females
  • Age 40-75 years
  • Indication for full colonoscopy for colorectal cancer screening or investigation, including subjects presenting suggestive symptoms and who need a differential diagnosis
  • Colonoscopy naïve subjects, i.e. who never underwent colonoscopy before, will be eligible, as well as non-naïve subjects who have previously undergone unsedated colonoscopy , or who had sedated colonoscopy at least 10 years prior (i.e. ≥ 10 years) to enrollment
  • Eligible for a procedure without sedation.
  • Able to complete questionnaires and use a Visual Analog Scale (VAS), including sufficient English, French or Spanish speaking skills as well as adequate eyesight and hearing
  • BMI ≥ 19, BMI ≤ 40 kg/m2

Exclusion Criteria

  • Known allergy or intolerance to trimebutine (Modulon® or generic)
  • Known allergy or intolerance to sulfur-containing drugs (e.g. N-acetylcysteine or captopril)
  • Previous gastrointestinal or gynecologic surgery, e.g. ileostomy, pelvic surgery
    • However,  an appendectomy is eligible.
    • A tubal ligation at least 10 years prior (i.e. ≥ 10 years) to enrollment is also eligible
  • Diagnosed Inflammatory Bowel Disease
  • Visceral hypersensitivity conditions such as Irritable Bowel Syndrome
  • Clinically significant renal and/or hepatic impairment
  • History of peritonitis
  • Known severe diverticular disease
  • Severe diverticulosis as documented by prior imaging series
  • Known or suspected stenosis of the colon
  • Chronic pain syndrome such as fibromyalgia and endometriosis
  • Any clinically-relevant abnormality identified on the screening, history, physical examination, 12-lead ECG or laboratory examination, which would, in the Investigator's opinion, preclude the administration of investigational drug product, GIC1001
  • Unexpected and significant visceral pain reported by subject prior to colonoscopy
  • Dementia
  • Diagnosed clinically significant psychiatric illness, including severe anxiety disorders that may affect the subject's perception of visceral pain or ability to participate in the study
  • Lactating
  • Female, of childbearing potential and sexually active, unwilling or unable to use an acceptable method of contraception ( includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or a sterile sexual partner) throughout the duration of the study and 1 month following study completion
  • Female, of childbearing potential, sexually abstinent, does not agree to continue abstinence or  use one of the acceptable methods of birth control should sexual activity commence
  • Any serious medical condition that could increase the risk of adverse reactions with trimebutine
  • Participation in another experimental drug trial within 30 days of randomization

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Larson, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Suryakanth Gurudu, M.D.

Closed for enrollment

More information


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